Device Classification Name |
System, Image Processing, Radiological
More FDA Info for this Device |
510(K) Number |
K221627 |
Device Name |
System, Image Processing, Radiological |
Applicant |
Yukun (Beijing) Technology Co., Ltd.
Room 313, 315, Building 3, No.11 Chuangxin Road,
Science Park, Changping District
Beijing 102200 CN
Other 510(k) Applications for this Company
|
Contact |
Qi Wang
Other 510(k) Applications for this Contact |
Regulation Number |
892.2050
More FDA Info for this Regulation Number |
Classification Product Code |
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/06/2022 |
Decision Date |
01/19/2023 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|